We support pharmaceutical companies across the entire product lifecycle—from early‑stage research and development to regulatory submission, commercialization, and post‑marketing surveillance. Our teams work with highly specialized content that demands scientific accuracy, regulatory alignment, and absolute consistency.
Our expertise includes:
- Clinical trial documentation Protocols, IBs, ICFs, CSR sections, recruitment materials, and all supporting study documentation.
- Investigator brochures Scientifically precise, regulator‑ready translations that maintain the integrity of complex clinical and preclinical data.
- IMPD / IND / CTA submissions High‑stakes regulatory submissions translated with strict adherence to EMA, FDA, and regional authority requirements.
- Pharmacovigilance reports ICSRs, DSURs, PSURs/PBRERs, RMPs, and safety‑related updates requiring accuracy, traceability, and compliance.
- Patient information leaflets (PILs) Clear, patient‑friendly translations that preserve readability while meeting regulatory formatting and terminology standards.
- Manufacturing and quality documentation SOPs, batch records, validation protocols, QC/QA documentation, and GMP‑aligned materials.
Our deep familiarity with pharmaceutical workflows ensures that every translation supports scientific clarity, regulatory compliance, and smooth progression through each stage of the product lifecycle.
medicaltranslations.gr 